MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRIO ST; SURGICAL MESH

Catalog Number	5950080
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	01/29/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.A lot number has not been provided; therefore, we are unable to review the manufacturing records of the lot in question.The information is limited at this time and medical records have not been provided.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the ventrio st (device 1).An additional emdr was submitted to represent the other bard/davol device.Not returned.
Event or Problem Description
It is alleged by the patient's attorney that the patient underwent surgery for implant of an unspecified bard/davol ventrio st (device 1 and device 2) on (b)(6) 2012 and (b)(6) 2014.It is also alleged by patient attorney that on (b)(6) /2017, the patient had unspecified injuries.As reported, the patient is making a claim for an adverse patient outcome against the two ventrio st devices.As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.".
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.A lot number has not been provided; therefore, we are unable to review the manufacturing records of the lot in question.The information is limited at this time and medical records have not been provided.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the date of event.Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-mar-2012) is considered to be a best estimate.This supplemental emdr represents the bard/davol ventrio st (device 1).An additional supplemental emdr was submitted to represent the bard/davol ventrio st (device 2).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It is alleged by the patient's attorney that the patient underwent surgery for implant of an unspecified bard/davol ventrio st (device 1 and device 2) on (b)(6) 2012 and (b)(6) 2014.It is also alleged by patient attorney that on (b)(6) 2017, the patient had unspecified injuries.As reported, the patient is making a claim for an adverse patient outcome against the two ventrio st devices.As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." addendum per additional information provided: (b)(6) 2012- patient was diagnosed with recurrent ventral incisional hernia, thereby underwent open repair with implant of ventrio st mesh (device 1).Per op notes, ¿the hernia sac with omentum was identified in abdominal region and dissected, the omentum was reduced.The old mesh was completely excised.A ventrio st mesh (device 1) was placed on the hernia defect and sutured¿.(note: the old mesh seen during this procedure was unknown) (b)(6) 2014- patient was diagnosed with recurrent ventral incisional hernia, thereby underwent open repair with partial explant of ventrio st mesh (device 1) and implant of ventrio st mesh (device 2).Per op notes, ¿the old scar tissue was excised.It was noticed that the ventrio st mesh (device 1) was not adhered and was resected back where it is actually attached and it was cut out.Intraperitoneal adhesions were freed up and a ventrio st mesh (device 2) was placed in the hernia defect and was sutured¿.

• Brand Name: VENTRIO ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 8524428
• Report Number: 1213643-2019-03122
• Device Sequence Number: 2689539
• Product Code: FTL
• UDI-Device Identifier: 00801741031571
• UDI-Public: (01)00801741031571(17)140328(10)HUWC1584
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2014
• Device Catalogue Number: 5950080
• Device Lot Number: HUWC1584
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male